A Phase 3 interventional study of Topical roflumilast in Chronic Plaque Psoriasis, sponsored by Arcutis Biotherapeutics, Inc.. Completed at 85 sites in 3 countries. Open to participants aged 2 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Arcutis Biotherapeutics, Inc. · Phase 3, Interventional, and Treatment
This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 24 weeks by subjects with chronic plaque psoriasis
This is an open-label study in which ARQ-151 cream is applied once daily x 24 weeks to subjects with psoriasis
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's enrollment of 337 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Arcutis Biotherapeutics, Inc. is the lead sponsor of 26 studies on the registry; 2 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 20 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects with chronic plaque psoriasis who meet eligibility criteria and:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Topical roflumilast
Active treatment
Also known as: ARQ-151 Cream 0.3%
Percentage of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs)
The percentage of participants with ≥TEAE is reported.
Time frame: Up to 24 weeks
Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
The percentage of participants with ≥1 SAE is reported.
Time frame: Up to 24 weeks
Achievement of an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Over Time
The percentage of participants achieving an IGA score of 0 or 1 is reported. The IGA is a 5-point scale assessing the severity of skin issues, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Time frame: Weeks 4, 12, and 24
Duration of Response (DOR) for Participants Achieving an IGA Score of 'Clear' or 'Almost Clear'
The Kaplan-Meier (KM) median DOR (days) of IGA score of clear or almost clear is reported. The IGA is a 5-point scale assessing the severity of skin issues, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. The duration of response starts with the first assessment of clear or almost clear, which could be as early as the Week 2 assessment in the feeder study, and continues until the participant's disease worsens or completes their involvement in the study. Therefore, the time variable could be as long as 30 weeks, 6 weeks in the feeder study plus 24 weeks in the ARQ-151-306 study.
Time frame: Up to Week 30
Return to IGA Score of ≥2 After Achieving an IGA Score of 'Clear' or 'Almost Clear'
The percentage of participants worsening to IGA Score of ≥2 after achieving an IGA score of clear or almost clear is reported. The IGA is a 5-point scale assessing the severity of skin issues, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Time frame: Up to Week 24
Achievement of a 50% Reduction in Psoriasis Area Severity Index (PASI-50) Score Over Time
The percentage of participants achieving PASI-50 is reported. The PASI is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity.
Time frame: Weeks 4, 12, and 24
Achievement of a 75% Reduction in Psoriasis Area Severity Index (PASI-75) Score Over Time
The percentage of participants achieving PASI-75 is reported. The PASI is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity.
Time frame: Weeks 4, 12, and 24
Achievement of a 90% Reduction in Psoriasis Area Severity Index (PASI-90) Score Over Time
The percentage of participants achieving PASI-90 is reported. The PASI is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity.
Time frame: Weeks 4, 12, and 24
Achievement of a 100% Reduction in Psoriasis Area Severity Index (PASI-100) Score Over Time
The percentage of participants achieving PASI-100 is reported. The PASI is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity.
Time frame: Weeks 4, 12, and 24
Achievement of Success in Worst Itch Numeric Rating Scale (WI-NRS) Score Over Time
The percentage of participants achieving WI-NRS success is reported. WI-NRS "success" is defined as a ≥4 point improvement from a baseline score of ≥4. The WI-NRS is a simple, single item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the past 24 hours. Higher scores indicate greater symptom severity.
Time frame: Weeks 4, 12, and 24
| Milestone | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream |
|---|---|---|---|
| Started | 264 | 9 | 60 |
| Completed | 232 | 6 | 56 |
| Not completed | 32 | 3 | 4 |
| Withdrew: Lost to follow-up | 15 | 1 | 1 |
| Withdrew: Withdrawal by subject | 12 | 1 | 3 |
| Withdrew: Miscellaneous | 2 | 1 | 0 |
| Withdrew: Noncompliance | 2 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 |
The percentage of participants with ≥TEAE is reported.
| percentage of participants | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream |
|---|---|---|---|
| Percentage of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs) | 26.1 | 33.3 | 56.7 |
The percentage of participants with ≥1 SAE is reported.
| percentage of participants | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream |
|---|---|---|---|
| Percentage of Participants With ≥1 Serious Adverse Events (SAEs) | 1.1 | 0 | 1.7 |
The percentage of participants achieving an IGA score of 0 or 1 is reported. The IGA is a 5-point scale assessing the severity of skin issues, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
| percentage of participants | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream |
|---|---|---|---|
| Week 4 | 41.2 | 33.3 | 26.7 |
| Week 12 | 58.1 | 83.3 | 56.1 |
| Week 24 | 49.1 | 83.3 | 73.2 |
The Kaplan-Meier (KM) median DOR (days) of IGA score of clear or almost clear is reported. The IGA is a 5-point scale assessing the severity of skin issues, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. The duration of response starts with the first assessment of clear or almost clear, which could be as early as the Week 2 assessment in the feeder study, and continues until the participant's disease worsens or completes their involvement in the study. Therefore, the time variable could be as long as 30 weeks, 6 weeks in the feeder study plus 24 weeks in the ARQ-151-306 study.
| days | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream |
|---|---|---|---|
| Duration of Response (DOR) for Participants Achieving an IGA Score of 'Clear' or 'Almost Clear' | 189 (1 to 222) | NA (1 to 190) | NA (1 to 147) |
The percentage of participants worsening to IGA Score of ≥2 after achieving an IGA score of clear or almost clear is reported. The IGA is a 5-point scale assessing the severity of skin issues, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
| percentage of participants | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream |
|---|---|---|---|
| Return to IGA Score of ≥2 After Achieving an IGA Score of 'Clear' or 'Almost Clear' | 25.8 | 11.1 | 5.0 |
The percentage of participants achieving PASI-50 is reported. The PASI is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity.
| percentage of participants | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream |
|---|---|---|---|
| Week 4 | 65.6 | 55.6 | 63.3 |
| Week 12 | 75.2 | 100.0 | 84.2 |
| Week 24 | 68.8 | 83.3 | 85.7 |
The percentage of participants achieving PASI-75 is reported. The PASI is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity.
| percentage of participants | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream |
|---|---|---|---|
| Week 4 | 32.0 | 33.3 | 23.3 |
| Week 12 | 49.2 | 50.0 | 63.2 |
| Week 24 | 42.7 | 50.0 | 69.6 |
The percentage of participants achieving PASI-90 is reported. The PASI is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity.
| percentage of participants | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream |
|---|---|---|---|
| Week 4 | 12.0 | 11.1 | 6.7 |
| Week 12 | 26.4 | 50.0 | 33.3 |
| Week 24 | 23.9 | 50.0 | 51.8 |
The percentage of participants achieving PASI-100 is reported. The PASI is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity.
| percentage of participants | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream |
|---|---|---|---|
| Week 4 | 7.2 | 11.1 | 3.3 |
| Week 12 | 15.4 | 33.3 | 21.1 |
| Week 24 | 15.4 | 33.3 | 35.7 |
The percentage of participants achieving WI-NRS success is reported. WI-NRS "success" is defined as a ≥4 point improvement from a baseline score of ≥4. The WI-NRS is a simple, single item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the past 24 hours. Higher scores indicate greater symptom severity.
| percentage of participants | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream |
|---|---|---|---|
| Week 4 | 56.7 | 25.0 | 53.8 |
| Week 12 | 67.1 | 50.0 | 70.3 |
| Week 24 | 60.2 | 50.0 | 72.2 |
Collected over Up to ~24 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | 0/264 (0%) | 3/264 (1.1%) | 10/264 (3.8%) |
| Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | 0/9 (0%) | 0/9 (0%) | 3/9 (33.3%) |
| Cohort 2: No Prior Roflumilast Cream | 0/60 (0%) | 1/60 (1.7%) | 26/60 (43.3%) |
| Event | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream |
|---|---|---|---|
| AppendicitisInfections and infestations | 0/264 | 0/9 | 1/60 |
| PalpitationsCardiac disorders | 1/264 | 0/9 | 0/60 |
| COVID-19 pneumoniaInfections and infestations | 1/264 | 0/9 | 0/60 |
| DehydrationMetabolism and nutrition disorders | 1/264 | 0/9 | 0/60 |
| Polycythaemia veraNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/264 | 0/9 | 0/60 |
| SyncopeNervous system disorders | 1/264 | 0/9 | 0/60 |
| Event | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream |
|---|---|---|---|
| NasopharyngitisInfections and infestations | 4/264 | 0/9 | 16/60 |
| HeadacheNervous system disorders | 8/264 | 0/9 | 12/60 |
| InfluenzaInfections and infestations | 4/264 | 0/9 | 7/60 |
| Abdominal pain upperGastrointestinal disorders | 1/264 | 1/9 | 1/60 |
| Application site painGeneral disorders | 1/264 | 1/9 | 0/60 |
| Skin bacterial infectionInfections and infestations | 0/264 | 1/9 | 0/60 |
| Decreased appetiteMetabolism and nutrition disorders | 3/264 | 1/9 | 0/60 |
| PyrexiaGeneral disorders | 0/264 | 0/9 | 4/60 |
| Age, Continuous(years) | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream | Total |
|---|---|---|---|---|
| Mean | 47.9 ± 15.79 | 9.8 ± 3.80 | 7.5 ± 3.52 | 39.6 ± 21.57 |
| Sex: Female, Male(Participants) | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream | Total |
|---|---|---|---|---|
| Female | 108 | 4 | 23 | 135 |
| Male | 156 | 5 | 37 | 198 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream | Total |
|---|---|---|---|---|
| Hispanic or Latino | 60 | 4 | 40 | 104 |
| Not Hispanic or Latino | 204 | 5 | 20 | 229 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Cohort 1 Group 1: Prior Roflumilast Cream 0.3% | Cohort 1 Group 2: Prior Roflumilast Cream 0.3% | Cohort 2: No Prior Roflumilast Cream | Total |
|---|---|---|---|---|
| American-Indian or Alaska Native | 1 | 0 | 1 | 2 |
| Asian | 13 | 0 | 4 | 17 |
| Black or African-American | 15 | 0 | 39 | 54 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 0 | 2 |
| White | 222 | 9 | 15 | 246 |
| Not reported | 0 | 0 | 0 | 0 |
| Other | 11 | 0 | 0 | 11 |
| Multiple | 0 | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Roflumilast
Arcutis Biotherapeutics, Inc. →